On May 11, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the first quarter ended March 31, 2020 (Press release, Mustang Bio, MAY 11, 2020, View Source [SID1234557553]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We were pleased to announce several important milestones in the first few months of 2020. Most notably, we were excited to submit our Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for MB-107, our lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency ("XSCID"), also known as bubble boy disease, and we look forward to commencing a multi-center Phase 2 clinical trial in newly diagnosed infants with XSCID under the age of two. We also anticipate filing a second IND in the third quarter of this year for a multi-center trial for the treatment of previously transplanted XSCID patients. Additionally, the European Medicines Agency ("EMA") granted Advanced Therapy Medicinal Product ("ATMP") classification to MB-107, which is an important step in establishing our path to market approval and commercialization in Europe."

"Among our other first quarter accomplishments was the complete response achieved at the lowest dose level in the first subject treated following process optimization in our Phase 1/2 clinical trial of MB-106, our CD20-targeted, autologous CAR T cell therapy, for patients with relapsed or refractory B-cell non-Hodgkin lymphomas. This trial is ongoing, and we hope to announce additional interim data later this year. We are also very pleased to report that MB-105, a PSCA-directed CAR T currently under investigation in a Phase 1 trial at City of Hope, appeared to be active in the first patient to receive the therapy following a standard CAR T conditioning regimen. As we progress through 2020, we look forward to advancing our gene and CAR T cell therapies toward additional potentially value-creating regulatory and clinical milestones in the months ahead," Dr. Litchman concluded.

Recent Corporate Highlights:

·In May 2020, Mustang submitted an IND application with the FDA to initiate a multi-center Phase 2 clinical trial of MB-107 in newly diagnosed infants with XSCID who are under the age of two. The trial is expected to enroll 10 patients who, together with 15 patients enrolled in the current multicenter trial led by St. Jude Children’s Research Hospital, will be compared with 25 matched historical control patients who have undergone hematopoietic stem cell transplant ("HSCT"). The primary efficacy endpoint will be event-free survival. The initiation of this trial is currently on hold pending CMC clearance by the FDA. Mustang is targeting topline data from the trial in the second half of 2022.
·Mustang further expects to file an IND in the third quarter of 2020 for a registrational multi-center Phase 2 clinical trial of its lentiviral gene therapy in previously transplanted XSCID patients. This product will be designated MB-207. Mustang anticipates enrolling 20 patients and comparing them to matched historical control patients who have undergone a second HSCT. Mustang is targeting topline data for this trial in the second half of 2022.
·In the ongoing Phase 1 trial at City of Hope with MB-105, a PSCA-directed CAR T administered systemically to patients with PSCA-positive castration resistant prostate cancer, the first patient to receive the therapy following a standard CAR T conditioning regimen experienced a significant reduction in his prostate-specific antigen ("PSA") at day 28. This PSA response was associated with radiographic improvement of the patient’s metastatic disease.

In April 2020, Mustang announced that the EMA granted ATMP classification to MB-107 for the treatment of XSCID.
·In February 2020, Mustang announced that the first subject treated with the optimized MB-106 (CD20-targeted, autologous CAR T cell therapy) manufacturing process, developed in collaboration between Mustang and Fred Hutchinson Cancer Research Center, achieved a complete response at the lowest starting dose in an ongoing Phase 1/2 clinical trial. The trial is evaluating the safety and efficacy of MB-106 in subjects with relapsed or refractory B-cell non-Hodgkin lymphomas.

Financial Results:

·As of March 31, 2020, Mustang’s cash, cash equivalents and restricted cash totaled $56.8 million, compared to $62.4 million as of December 31, 2019, a decrease of $5.6 million for the first quarter.
·Research and development expenses were $9.3 million for the first quarter of 2020. This compares to $7.0 million for the first quarter of 2019. Non-cash, stock-based compensation expenses included in research and development were $0.4 million for the first quarter of 2020, compared to $0.1 million for the first quarter of 2019.
·Research and development expenses from license acquisitions totaled $0.3 million for the first quarter of 2020, compared to $0.5 million for the first quarter of 2019.
·General and administrative expenses were $2.0 million for the first quarter of 2020. This compares to $2.3 million for the first quarter of 2019. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.4 million for the first quarter of 2020, compared to $0.7 million for the first quarter of 2019.
·Net loss attributable to common stockholders was $11.9 million, or $0.28 per share, for the first quarter of 2020, compared to a net loss attributable to common stockholders of $9.6 million, or $0.34 per share, for the first quarter of 2019.

On May 11, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported the release of the GMP Cloudz Human T Cell Activation Kit (Press release, Bio-Techne, MAY 11, 2020, View Source [SID1234557552]). This is the first GMP-grade kit within the Cloudz product line addressing the need for robust, yet safe products within the clinical- and commercial-scale of the Cell and Gene Therapy manufacturing process . The kit contains Cloudz particles, which are dissolvable microspheres conjugated to GMP Grade, in-house manufactured CD3 and CD28 antibodies for the expansion of T cells. The GMP Cloudz Human T Cell Activation Kit seamlessly fits within the T cell culture platform, and the particles are easily washed away from cells of interest. Cloudz particles can be added to CD3+ T cells or PBMCs for efficient expansion and purity of cells. The unique properties of the Cloudz microspheres allow them to be readily dissolved and washed away with a GMP-Grade Cloudz Release Buffer.

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Cell and Gene Therapies have gained significant traction over the last decade following the commercial success of CAR-T Cell therapeutics and include a substantial pipeline of therapies within clinical trials. The Cloudz product line is part of the larger cell and gene therapy portfolio that Bio-Techne has created over the last year that now includes several ExCellerate media formulations, GMP proteins, and gene-editing platforms with additional products in the pipeline.

"The GMP Cloudz T Cell activation kit is an important tool within CAR-T and other immune cell therapies providing a much-needed bead-free cell expansion platform," commented Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "It is an exciting time within Cell and Gene Therapy, and we are proud to be a part of this important area of science."

On May 11, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that cGMP Validation, the company’s GMP consultant, is conducting its final audit of the manufacturing facility in Thailand where PharmaCyte’s clinical trial product was produced by PharmaCyte’s partner, Austrianova Singapore (Austrianova) (Press release, PharmaCyte Biotech, MAY 11, 2020, View Source [SID1234557546]). When the audit is completed, cGMP Validation will give PharmaCyte approval to import the clinical trial product to the company’s supply chain vendor in the United States (U.S.) who will store the product at -80C until it is needed.

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In addition, Austrianova and cGMP Validation have now completed their work together to achieve what has been deemed cGMP compliant batch records for the two manufacturing runs successfully produced by Austrianova. Both worked closely together to revise the batch records that were generated during the two manufacturing runs that produced PharmaCyte’s clinical trial product for its planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). A batch record is a detailed written document of a manufactured batch of product, prepared during a pharmaceutical manufacturing process. A batch record contains actual data and the step by step process for manufacturing each batch. The completed manufacturing batch records are proof that the two batches were properly made and checked by quality control personnel at Austrianova according to cGMP standards. This was necessary so that the batches comply with the standards required by the U.S. Food and Drug Administration (FDA) for a batch record for each manufacturing run.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We continue to work through a checklist of items that are necessary to submit an acceptable Investigational New Drug application (IND) to the FDA. The work that cGMP Validation and Austrianova are currently performing to audit the manufacturing facility in Thailand and the work they have completed working together to make certain the batch records meet the cGMP requirements for manufacturing a clinical trial product was and continues to be incredibly detailed and must continue to follow strict FDA guidelines.

"We are extremely pleased that the final audit of the manufacturing facility is underway and that our batch records from the two successful manufacturing runs meet all FDA cGMP requirements as the product is not considered a cGMP product unless it meets these stringent standards."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On May 11, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported financial results for the quarter ended March 31, 2020 (Press release, Zimmer Holdings, MAY 11, 2020, View Source [SID1234557544]). The Company reported first quarter net sales of $1.784 billion, a decrease of 9.7% from the prior year period, and a decrease of 8.9% on a constant currency basis – both consistent with the preliminary results disclosed in the Company’s press release on April 6, 2020. Net loss for the first quarter was $509 million, including goodwill impairment. Net earnings on an adjusted basis were $354 million.

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Diluted loss per share was $2.46 for the first quarter. Adjusted diluted earnings per share were $1.70 for the first quarter, a decrease of 9.1% from the prior year period.

"While our full first quarter results have been impacted by the global spread of COVID-19 and the deferral of elective procedures, our operational performance prior to the COVID-19 disruption was trending ahead of our expectations," said Bryan Hanson, President and CEO of Zimmer Biomet. "Over the past two years, we have made significant strides in reshaping and evolving Zimmer Biomet. This progress has better positioned us to address the COVID-19 challenge. We have an innovative and mobilized team, operational scale and increased financial flexibility – all of which we are using to support healthcare professionals and patients. I continue to be so proud of our global team and our collective, unyielding commitment to the ZB mission to better the lives of people around the world."

First quarter performance was negatively impacted by COVID-19, which reached a pandemic level in March and resulted in a significant and sudden global decline in elective procedure volumes.

Please see the attached schedules accompanying this press release for additional details on performance in the quarter, including sales by Zimmer Biomet’s three geographies and five product categories.

Geographic and Product Category Sales

The following sales table provides results by geography and product category for the three-month period ended March 31, 2020, as well as the percentage change compared to the prior year period, on both a reported basis and a constant currency basis.

Cash Flow and Balance Sheet

Operating cash flow for the first quarter was $451 million and free cash flow was $325 million. In the first quarter, the Company paid $50 million in dividends and declared a dividend of $0.24 per share. The Company also recently refinanced $1.5 billion in debt that came due April 1, 2020, renegotiated the terms of its $1.5 billion revolver and secured an additional $1.0 billion credit facility.

Financial Guidance

Zimmer Biomet expects the decline in elective procedure volumes observed in the final weeks of the first quarter to continue to have a significant negative impact in the second quarter of 2020. Given the uncertainty around the scope and duration of COVID-19 and its ongoing impact on the deferral of elective procedures, the Company is currently unable to quantify the expected impact on its results of operations, financial condition and cash flows, which could be material, for 2020 and is therefore not providing full-year financial guidance.

Conference Call

The Company will conduct its first quarter 2020 investor conference call today, May 11, 2020, at 8:30 a.m. Eastern Time. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

On May 11, 2020 Cardinal Health (NYSE: CAH) reported financial results for the third quarter of fiscal 2020 ended March 31, 2020 (Press release, Cardinal Health, MAY 11, 2020, View Source [SID1234557543]).Third quarter revenue was $39.2 billion, an increase of 11% from the third quarter of last year.

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Third quarter GAAP operating earnings increased 30% to $562 million. Non-GAAP operating earnings increased 8% to $719 million. GAAP diluted earnings per share (EPS) increased 20% to $1.19, while non-GAAP diluted EPS increased 2% to $1.62.

"I want to express my gratitude to our employees and our partners across the healthcare industry for their incredible efforts to help us perform our critical role in the supply chain during this unprecedented time," said Mike Kaufmann, CEO of Cardinal Health. "We remain committed to delivering products and solutions to front-line health care providers so they can safely serve and treat patients around the world. As we look toward and beyond the fourth quarter, we will continue to take strategic actions to fulfill this mission."

Third quarter revenue for the Pharmaceutical segment increased 12 percent to $35.1 billion, due to sales growth from Pharmaceutical Distribution customers and, to a lesser extent, Specialty Solutions customers. This growth included an acceleration in overall pharmaceutical sales in March, which the company believes was due to the COVID-19 pandemic.

Pharmaceutical segment profit was flat at $534 million in the third quarter. This reflects strong performance in the company’s generics program and the adverse impact of Pharmaceutical Distribution customer contract renewals.

Medical segment

Third quarter revenue for the Medical segment increased 5 percent to $4.1 billion, due to growth in products and distribution and Cardinal Health at Home.

Medical segment profit increased 15 percent to $178 million in the third quarter due to an increase in products and distribution, including benefits from global manufacturing and cost savings initiatives.

Fiscal year 2020 outlook
While both segments experienced a modest net positive impact in the third quarter from increased volume related to the COVID-19 pandemic, the company expects a significant net negative impact to fourth quarter financial results in both segments. This is driven most meaningfully by a decrease in volume related to the cancellation or deferral of elective medical procedures.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company reaffirms its fiscal year 2020 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $5.20 to $5.40.

Recent highlights

Jason Hollar joined the company on April 27 and will become Chief Financial Officer on May 26. Jason previously served as CFO of Tenneco Inc. and Sears Holdings Corporation.
Cardinal Health board of directors approved a quarterly dividend of $0.4859 per share. The dividend will be payable on July 15, 2020 to shareholders of record at the close of business on July 1, 2020.
The company was recognized as a "2020 NAFE Top Companies for Executive Women" by the National Association for Female Executives for the ninth consecutive year.
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss third quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until May 10, 2021.